Nasal oral respiratory interface

Abstract

The present invention provides an apparatus and a method for stabilizing at least one medical device such as a tracheal or gastric tube entering or covering at least one facial cavity such as the mouth and/or nose, taking advantage of a stabilization stent to secure to a patient's face the tracheal or gastric tube without the need to apply tape to the face, while maintaining visibility of tube markings, preventing kinking of the tube, and keeping the infant's face visible to parents and caregivers. In one form, the invention comprises a transverse stent comprising a superior border opposed to an inferior border, an inner surface and an outer surface. A first facial interface is attached to a first terminal end of the transverse stent, and positioned to adhesively adhere and mechanically clasp to a first side of a patient's face. A second facial interface is attached to a second terminal end of the transverse stent and positioned to adhesively adhere and mechanically clasp to a second side of a patient's face. A docking platform attached to the outer surface of the transverse stent supports the medical device. In a different form, the invention also includes gutters positioned on the inner surface of the respective first and second terminal end approximate to the respective first and second facial interface to channel oral fluids away from the respective first and second facial interface. The outer surface contains channels for containing and directing tubing, and fixaton points for attaching anchoring measures such as chin or head straps. The core of the transverse stent is hollowed to permit gas flow.

What I claim is:  
     
       1. An apparatus for stabilizing at least one medical device entering at least one facial cavity of a patient's face comprising: 
       a transverse stent having a superior border, the superior border having a first end and a second end, an inferior border opposed to the superior border, the inferior border having a first end and a second end, an outer surface extending between the superior border and the inferior border from the first end of the superior border and the inferior border to the second end of the superior border and the inferior border, an inner surface extending between the superior border and the inferior border from the first end of the superior border and the inferior border to the second end of the superior border and the inferior border, the outer surface facing away from a facial cavity and opposed to the inner surface;  
       first facial interface attached to a first end of the transverse stent, the first end extending between the first end of the superior border of the transverse stent and the first end of the inferior border of the transverse stent, wherein the first facial interface includes a surface positioned adjacent a first side of the patient's face;  
       a second facial interface attached to a second end of the transverse stent, the second end extending between the second end of the superior border of the transverse stent and the second end of the inferior border of the transverse stent, wherein the second facial interface includes a surface positioned adjacent a second side of the patient's face;  
       a docking platform attached to the outer surface of the transverse stent at a preselected angle, the docking platform for supporting at least one medical device;  
       and means for attaching the first and second facial interfaces to the first and second sides of the patient's face, the means for attaching comprising structure to mechanically clasp a patient's face.  
     
     
       2. The apparatus of  claim 1  wherein the means for attaching the first and second facial interfaces to the first and second sides of the patient's face is selected from the group consisting of adhesively adhering, mechanically clasping and combinations thereof. 
     
     
       3. The apparatus of  claim 2  wherein the means for attaching includes a hydrocolloid adhesive. 
     
     
       4. The apparatus of  claim 2  wherein the means for attaching includes a pectin based adhesive. 
     
     
       5. The apparatus of  claim 2  wherein the means for attaching includes a substantially transparent, hypoallergenic adhesive. 
     
     
       6. The apparatus of  claim 1  wherein the transverse stent is of a predetermined length sufficient to provide mechanical clasping to the first and second sides of the patient's face. 
     
     
       7. The apparatus of  claim 1  wherein each of the first and second facial interfaces further includes an inferior border, at least a portion of each of the inferior borders of the first and second facial interface mechanically clasping an area of the patient's face overlying at least a portion of an inferior border of a patient's mandible. 
     
     
       8. The apparatus of  claim 7  wherein the at least a portion of the inferior border of the first and second facial interface are each offset medially about 5 degrees to about 35 degrees from a plane substantially parallel to the respective first and second side of the patient's face to mechanically clasp an area of the patient's face overlying at least a portion of the inferior border of a mandible of the patient. 
     
     
       9. The apparatus of  claim 1  wherein the means for attaching the first and second facial interfaces to the first and second sides of the patient's face is an adhesive intermediate the facial interface and the patient's face. 
     
     
       10. The apparatus of  claim 9  wherein the first and second facial interfaces are substantially contoured to a contour of the respective first and second side of the patient's face. 
     
     
       11. The apparatus of  claim 1  wherein the means for attaching the first and second facial interfaces to the first and second sides of the patient's face is an adhesive applied to the first and second sides of the patient's face intermediate the facial interface and the face. 
     
     
       12. The apparatus of  claim 11  wherein the first and second facial interfaces are substantially contoured to a contour of the respective first and second side of the patient's face. 
     
     
       13. The apparatus of  claim 1  wherein the transverse stent is substantially arch shaped to position the transverse stent a predetermined distance above a maxillary lip of the patient. 
     
     
       14. The apparatus of  claim 13  wherein the transverse stent is positioned about 1 mm to about 3 mm above the patient's maxillary lip. 
     
     
       15. The apparatus of  claim 1  wherein the transverse stent is comprised of a material that is substantially transparent and hypo-allergenic. 
     
     
       16. The apparatus of  claim 1  wherein at least a portion of the apparatus is fabricated from a pliable, activatable material capable of being activated to achieve a permanent predetermined shape after the apparatus is contoured to the predetermined shape. 
     
     
       17. The apparatus of  claim 1  further including at least one anchorage attachment to receive an attachment point from at least one additional anchorage. 
     
     
       18. The apparatus of  claim 1  wherein the at least one anchorage attachment is positioned on a surface opposed to the surfaces adjacent to the patient's face. 
     
     
       19. The apparatus of  claim 17  wherein the at least one anchorage attachment is selected from the group consisting of button, hook, loop, slot, tab and combinations thereof. 
     
     
       20. The apparatus of  claim 1  wherein the transverse stent further comprises a first and second gutter positioned on the inner surface of the transverse stent proximate to the respective first and second facial interfaces, positioned to channel oral fluids away from the respective first and second facial interface after attachment to the patient's face. 
     
     
       21. The apparatus of  claim 1  wherein the transverse stent further comprises at least one mechanical retaining point to removably receive the at least one medical device, the at least one mechanical retaining point selected from the group consisting of a clip positioned on the stent outer surface, a channel positioned in the stent outer surface and combinations thereof. 
     
     
       22. The apparatus of  claim 1  wherein the transverse stent further comprises a hollow bore of predetermined diameter positioned to transport a gas, the bore comprising a first opening in the transverse stent to receive the supply of the gas and a second opening at the docking station to deliver the supply of the gas. 
     
     
       23. The apparatus of  claim 1  wherein the docking platform is permanently attached to the outer surface. 
     
     
       24. The apparatus of  claim 1  wherein the docking platform is removably attached to the outer surface. 
     
     
       25. The apparatus of  claim 1  wherein a universal docking station is fabricated within a surface of the transverse stent to removably receive the docking platform. 
     
     
       26. The apparatus of  claim 25  wherein the universal docking station is a recess that removably receives a projection extending from the docking platform. 
     
     
       27. The apparatus of  claim 1  wherein the docking platform comprises a cantilevered finger extending from the transverse stent. 
     
     
       28. The apparatus of  claim 27  wherein the cantilevered finger extends outward at an angle of about 95 degrees. 
     
     
       29. The apparatus of  claim 27  wherein the cantilevered finger includes a substantially flexible section of predetermined length and a substantially rigid section of predetermined length, the rigid section extending from the stent and the flexible length extending from the rigid length. 
     
     
       30. The apparatus of  claim 27  wherein the cantilevered finger further includes at least one channel positioned on at least one surface of the cantilevered finger for receiving the at least one medical device. 
     
     
       31. The apparatus of  claim 30  wherein the at least one channel includes a first channel positioned on a top surface of the cantilevered finger and a second channel positioned on a bottom surface of the cantilevered finger. 
     
     
       32. The apparatus of  claim 27  wherein the cantilevered finger further includes a clamp attached to a bottom surface of the cantilevered finger, the clamp removably engaging the at least one medical device. 
     
     
       33. The apparatus of  claim 1  wherein the docking platform is a CPAP cannula. 
     
     
       34. The apparatus of  claim 1  wherein the transverse stent further includes a groove in the superior surface to support the at least one medical device. 
     
     
       35. The apparatus of  claim 1  wherein each facial interface is curved between inferior and superior borders. 
     
     
       36. The apparatus of  claim 1  wherein each facial interface includes an anterior portion and a posterior portion, and the facial interface is curved between anterior and posterior portions. 
     
     
       37. The apparatus of  claim 1  wherein the transverse stent has a middle and further comprising an open area at or near the middle of the transverse stent along said superior border. 
     
     
       38. The apparatus of  claim 1  wherein each facial interface has perimeter dimensions larger than the stent between the facial interfaces, the facial interfaces shaped to substantially conform to contours of the patient's face, but having substantial stiffness. 
     
     
       39. An apparatus for stabilizing at least one medical device entering at least one facial cavity comprising: 
       a transverse stent positioned between a first and second facial interface, the first facial interface opposed to the second facial interface;  
       the first facial interface positioned adjacent a first side of a patient's face;  
       the second facial interface positioned adjacent a second side of a patient's face;  
       a means for supporting at least one medical device with the transverse stent;  
       a means for adhesively adhering the first and second facial interfaces to the first and second sides of the patient's face; and  
       a means for mechanically clasping the first and second facial interfaces to the first and second sides of the patient's face.  
     
     
       40. The apparatus of  claim 39  wherein each facial interface is curved between inferior and superior borders. 
     
     
       41. The apparatus of  claim 39  wherein each facial interface includes an anterior portion and a posterior portion, and the facial interface is curved between anterior and posterior portions. 
     
     
       42. The apparatus of  claim 39  wherein the transverse stent has a middle and further comprising an open area at or near the middle of the transverse stent along said superior border. 
     
     
       43. The apparatus of  claim 39  wherein each facial interface has perimeter dimensions larger than the stent between the facial interfaces, the facial interfaces shaped to substantially conform to contours of the patient's face, but having substantial stiffness. 
     
     
       44. A method for stabilizing at least one medical device entering at least one facial cavity of a patient's face comprising the steps of: 
       selecting at least one medical device;  
       inserting a first end of the at least one medical device into at least one facial cavity;  
       attaching a stabilizer to the patient's face, the stabilizer comprising:  
       a transverse stent having a superior border with a first end and a second end, an inferior border opposed to the superior border, the inferior border having a first end and a second end, an outer surface extending between the superior border and the inferior border from the first end of the superior border and the inferior border to the second end of the superior border and the inferior border, an inner surface extending between the superior border and the inferior border from the first end of the superior border and the inferior border to the second end of the superior border and the inferior border, the outer surface facing away from a facial cavity and opposed to the inner surface;  
       a first facial interface attached to a first end of the transverse stent, the first end extending between the first end of the superior border and the first end of the inferior border, wherein the first facial interface is positioned adjacent a first side of the patient's face;  
       a second facial interface attached to a second end of the transverse stent, the second end extending between the second end of the superior border and the second end of the inferior border, wherein the second facial interface is positioned adjacent a second side of the patient's face;  
       a docking platform attached to the outer surface of the transverse stent at a preselected angle, the docking platform for supporting the at least one medical device; and  
       a means for attaching the first and second facial interfaces to the first and second sides of the patient's face, the means for attaching comprising structure to mechanically clasp a patient's face; and  
       affixing a second end of the at least one medical device to the stabilizer.  
     
     
       45. The method of  claim 44  wherein the at least one medical device is selected from the group consisting of endotracheal tubes, nasaltracheal tubes, nasogastric tubes, orogastric tubes, nasojejunal tubes, orojejunal tubes, nasal thermistors, nasal pneumotachometers, nasal capnographs oxygen tubing, oxygen cannula, nasal CPAP delivery systems, nasal mask and face mask. 
     
     
       46. A system for stabilizing at least one medical device entering at least one facial cavity formed by the method of  claim 44 . 
     
     
       47. An apparatus for stabilizing at least one medical device entering at least one facial cavity of a patient's face comprising: 
       a transverse stent having a superior border, the superior border having a first end and a second end, an inferior border opposed to the superior border, the inferior border having a first end and a second end, an outer surface extending between the superior border and the inferior border from the first end of the superior border and the inferior border to the second end of the superior border and the inferior border, an inner surface extending between the superior border and the inferior border from the first end of the superior border and the inferior border to the second end of the superior border and the inferior border, the outer surface facing away from a facial cavity and opposed to the inner surface, the inner surface being substantially flat and having a distance between the superior and inferior border of the inner surface approximately at least one-third a distance between upper lip and nose of a patient at a portion of the stent adapted for placement at and near a patient's nose to allow the transverse stent some medial flex but deter flexing in other directions;  
       first facial interface attached to a first end of the transverse stent, the first end extending between the first end of the superior border of the transverse stent and the first end of the inferior border of the transverse stent, wherein the first facial interface includes a surface positioned adjacent a first side of the patient's face;  
       a second facial interface attached to a second end of the transverse stent, the second end extending between the second end of the superior border of the transverse stent and the second end of the inferior border of the transverse stent, wherein the second facial interface includes a surface positioned adjacent a second side of the patient's face;  
       a docking platform attached to the outer surface of the transverse stent at a preselected angle, the docking platform for supporting at least one medical device.  
     
     
       48. The apparatus of  claim 47  comprising a means for attaching the first and second facial interfaces to the first and second sides of the patent's face is selected from the group consisting of adhesively adhering, mechanically clasping and combinations thereof. 
     
     
       49. The apparatus of  claim 48  wherein the means for attaching includes a substantially transparent, hypoallergenic adhesive. 
     
     
       50. The apparatus of  claim 47  wherein the transverse stent is of a predetermined length sufficient to provide mechanical clasping to the first and second sides of the patient's face. 
     
     
       51. The apparatus of  claim 47  wherein each of the first and second facial interfaces further includes an inferior border, at least a portion of each of the inferior borders of the first and second facial interface mechanically clasping an area of the patient's face overlying at least a portion of an inferior border of a patient's mandible. 
     
     
       52. The apparatus of  claim 47  wherein at least a portion of the inferior border of the first and second facial interface are each offset medially about 5 degrees to about 35 degrees from a plane substantially parallel to the respective first and second side of the patient's face to mechanically clasp an area of the patient's face overlying at least a portion of the inferior border of a mandible of the patient. 
     
     
       53. The apparatus of  claim 47  wherein the first and second facial interfaces are substantially contoured to a contour of the respective first and second side of the patient's face. 
     
     
       54. The apparatus of  claim 47  wherein the transverse stent is substantially arch shaped to position the transverse stent a predetermined distance above a maxillary lip of the patient. 
     
     
       55. The apparatus of  claim 47  wherein the transverse stent is comprised of a material that is substantially transparent and hypo-allergenic. 
     
     
       56. A method for stabilizing at least one medical device entering at least one facial cavity of a patient's face comprising the steps of: 
       selecting at least one medical device;  
       inserting a first end of the at least one medical device into at least one facial cavity;  
       attaching a stabilizer to the patient's face, the stabilizer comprising:  
       a transverse stent having a superior border with a first end and a second end, an inferior border opposed to the superior border, the inferior border having a first end and a second end, an outer surface extending between the superior border and the inferior border from the first end of the superior border and the inferior border to the second end of the superior border and the inferior border, an inner surface extending between the superior border and the inferior border from the first end of the superior border and the inferior border to the second end of the superior border and the inferior border, the inner surface being substantially flat and having a distance between the superior and inferior border of the inner surface approximately at least one-third a distance between upper lip and nose of a patient at a portion of the stent adapted for placement at and near a patient's nose to allow the transverse stent some medial flex but deter flexing in other directions, the outer surface facing away from a facial cavity and opposed to the inner surface;  
       a first facial interface attached to a first end of the transverse stent, the first end extending between the first end of the superior border and the first end of the inferior border, wherein the first facial interface is positioned adjacent a first side of the patient's face;  
       a second facial interface attached to a second end of the transverse stent, the second end extending between the second end of the superior border and the second end of the inferior border, wherein the second facial interface is positioned adjacent a second side of the patient's face;  
       a docking platform attached to the outer surface of the transverse stent at a preselected angle, the docking platform for supporting the at least one medical device; and  
       a component adapted to attach the first and second facial interfaces to the first and second sides of the patient's face; and  
       affixing a second end of the at least one medical device to the stabilizer.  
     
     
       57. The method of  claim 56  wherein the stabilizer is adapted to attach the first and second facial interfaces to the first and second sides of the patent's face by one or more of adhesively adhering, mechanically clasping and combinations thereof. 
     
     
       58. The method of  claim 56  wherein the step of attaching includes a substantially transparent, hypoallergenic adhesive. 
     
     
       59. The method of  claim 56  wherein the transverse stent is of a predetermined length sufficient to provide mechanical clasping to the first and second sides of the patient's face. 
     
     
       60. The method of  claim 56  wherein each of the first and second facial interfaces further includes an inferior border, at least a portion of each of the inferior borders of the first and second facial interface mechanically clasping an area of the patient's face overlying at least a portion of an inferior border of a patient's mandible. 
     
     
       61. The method of  claim 56  wherein the at least a portion of the inferior border of the first and second facial interface are each offset medially about 5 degrees to about 35 degrees from a plane substantially parallel to the respective first and second side of the patient's face to mechanically clasp an area of the patient's face overlying at least a portion of the inferior border of a mandible of the patient. 
     
     
       62. The method of  claim 56  wherein the first and second facial interfaces are substantially contoured to a contour of the respective first and second side of the patient's face. 
     
     
       63. The method of  claim 56  wherein the transverse stent is substantially arch shaped to position the transverse stent a predetermined distance above a maxillary lip of the patient. 
     
     
       64. The method of  claim 56  wherein the transverse stent is comprised of a material that is substantially transparent and hypo-allergenic.